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Also known as Priorix-Tetra™ (MMRV vaccine 208136), MMRV vaccine (GSK208136)
Priorix-Tetra · 4 trials · 5 indications
Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.
Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.
Confirmed varicella case = A case that met the clinical case definition \[an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause\] at least in the opinion of the investigator and was confirmed by laboratory test \[Polymerase Chain Reaction (PCR) (+)\] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked \[Epi (+)\] to a valid index case.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies \[concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies \[titer greater than or equal to the threshold of 51 Effective Doses (ED50)\] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.
Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies \[concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.
Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies \[concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)\] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Concentrations are given as Geometric Mean Concentrations (GMCs).
| Arm | Type | Description |
|---|---|---|
| Group A | ACTIVE_COMPARATOR | Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49). |
| Group B | EXPERIMENTAL | Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0). |
| Group C | ACTIVE_COMPARATOR | Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49). |
| MMRV Group | EXPERIMENTAL | Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2). |
| OKAH Group | EXPERIMENTAL | Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm. |
| MMR Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2). |
| Priorix-Tetra new WS Group | EXPERIMENTAL | Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12. |
| Priorix-Tetra current WS Group | EXPERIMENTAL | Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12. |
| Name | Type | Description |
|---|---|---|
| PriorixTetra™ | BIOLOGICAL | One dose administered subcutaneously |
| Meningitec | BIOLOGICAL | One dose administered intramuscularly |
| Priorix-tetra™ | BIOLOGICAL | 2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group |
| Priorix™ | BIOLOGICAL | 2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group |
| Varilrix™ | BIOLOGICAL | 1 dose administered subcutaneously at Day 42 to subjects in OKAH Group |
| Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine) | BIOLOGICAL | Vaccine will be administered subcutaneously in the left upper arm (deltoid region) |
| GSK Biologicals' 208136, new formulation | BIOLOGICAL | Vaccine will be administered subcutaneously in the left upper arm (deltoid region) |
| Priorix-Tetra™ (MMRV vaccine 208136) | BIOLOGICAL | One subcutaneous injection. |
| ProQuad® | BIOLOGICAL | One subcutaneous injection. |
| Havrix® | BIOLOGICAL | Two intramuscular injections. |
| Prevnar® | BIOLOGICAL | One intramuscular injection. |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol. * A male or female between, and including, 13 and 15 months of age at the time of the first vaccination. * Written informed...
Priorix-Tetra is a combined vaccine intended to protect against measles, rubella, and varicella, with mumps also studied in its clinical program. It is given to healthy children, with trial participants as young as 11 months of age. It is an infectious disease vaccine developed by GSK plc.
Priorix-Tetra is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals conducted the clinical studies of the vaccine, including a Phase 3 study in Italy and a Phase 2 study comparing it with ProQuad in the United States.
Priorix-Tetra has been studied in Phase 2 and Phase 3 clinical trials, and all of those trials are completed. It is an investigational vaccine candidate in clinical development, and the available information does not indicate that it is FDA approved.
Priorix-Tetra has been evaluated in completed trials including NCT01506193, a Phase 3 immunogenicity and safety study with conjugated MenC vaccine in healthy children in Italy, and NCT00892775, a Phase 2 study of the 208136 formulation with new measles and rubella working seeds in Singapore and Taiwan.
Yes. Priorix-Tetra, PriorixTetra, PriorixTetra, and the MMRV vaccine 208136 are names for the same combined measles-mumps-rubella-varicella vaccine from GSK. Searches using any of these spellings refer to this single vaccine candidate.
Across the reported studies, 7,654 participants were enrolled in Priorix-Tetra trials. The largest was NCT00226499, a Phase 3 study of a combined vaccine against measles, mumps, rubella and chickenpox with 5,803 children across ten European countries. All trials were randomized, double-blind, and controlled.